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Quality Assurance Manager

Company: Orchid Orthopedics
Location: Arcadia
Posted on: June 19, 2022

Job Description:

SUMMARY OF POSITION
The Manager, Quality Assurance leads the quality team focused on implementing, developing, and improving Orchid's Quality Assurance and Compliance systems and processes. Responsibilities include but are not limited to implementation, maintenance, and effectiveness of the facility's Quality Management System (QMS).

The Manager, Quality Assurance works closely with the Site Quality Leader (Management Representative) and the General Manager of Orchid's facility in Arcadia, CA.

SHIFT
No Shift ($0) (United States of America)

WHAT YOU WILL DO

  • Define, maintain, and communicate the requirements in the Quality Management System (QMS) to ensure compliance.
  • Lead and develop team members in the Quality Assurance organization. Ensure the growth of our positive business culture through behaviors that align with our core values and leadership competencies.
  • Ensure team members have the required knowledge and skills prior to performing job duties independently, including conducting, documenting, and evaluating training effectiveness.
  • Accomplish business objectives and effective operation of the quality assurance organization by understanding, communicating, training, and enforcing policies and procedures related to medical device regulations and other internal/external requirements.
  • Responsible for planning, organizing, directing, and reporting certain compliance activities at the site as Deputy Management Representative
  • Develops novel data-driven approaches to monitor the effectiveness of the QMS using quality KPIs and analytical software.
  • Ensure effectiveness of supplier/vendor control processes with risk-based controls, monitoring and comprehensive process audits with documented follow up where gaps are identified.
  • Participate in internal and external audits to support the ongoing robustness of the QMS
  • Identify and/or lead continuous improvement/DMAIC projects to deliver cost savings and/or efficiency gains to the business
    WHAT WE ARE LOOKING FOR

    WORK EXPERIENCE
    2+ Years Supervising/Managing a Team (Required), 5+ Years of Experience in a Manufacturing Environment (Required), 5+ Years of Experience Leading Quality in A Regulated Industry (Required), Experience with FDA and ISO systems relating to medical devices (Preferred), Lean manufacturing experience (Preferred)

    EDUCATION
    Bachelor Required, Bachelor - Biology, Bachelor - Engineering, Bachelor - Quality Assurance

    CERTIFICATIONS
    Certified Manager of Quality/Organizational Excellence (CMQ/OE) - American Society for Quality (ASQ), Certified Six Sigma Blackbelt (CSSBB) - American Society for Quality (ASQ), Certified Six Sigma Greenbelt (CSSGB) - American Society for Quality (ASQ), Certified Six Sigma Yellow Belt - American Society for Quality (ASQ)

    KNOWLEDGE & SKILLS THAT ENABLE SUCCESS
    Change Leadership (Working Experience), Coaching (Working Experience), Collaboration (Extensive Experience), Computer Knowledge (Working Experience), Decision Making and Critical Thinking (Working Experience), Interpersonal Communication (Working Experience), Manufacturing Equipment (Basic Knowledge), Manufacturing Process (Basic Knowledge), Problem Solving (Working Experience), Project Management (Basic Knowledge), Quality Management (Working Experience), Results (Working Experience)

    WHAT WE OFFER
    • Opportunity to work in a growing company
    • Ability to help people live a longer, more active life
    • Comprehensive benefit package
    • Ability to work in an organization that values:
      • Integrity First: We do the right thing
      • Teamwork: We are one Orchid
      • Results: Our results matter
        PHYSICAL REQUIREMENTS
        • Performs work sitting at a desk and working on a computer
        • Regularly walks or stands in a production shop floor environment
          ADDITIONAL REQUIREMENTS
          • Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
          • Candidates must be able to provide proof of eligibility to work in the United States through eVerify
            EOE, including disability/vets

Keywords: Orchid Orthopedics, Arcadia , Quality Assurance Manager, Executive , Arcadia, California

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